Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K140522 |
Device Name |
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL |
Applicant |
RANDOX LABORATORIES LIMITED |
55 DIAMOND RD. |
CRUMLIN, CO.ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
PAULINE ARMSTRONG |
Correspondent |
RANDOX LABORATORIES LIMITED |
55 DIAMOND RD. |
CRUMLIN, CO.ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
PAULINE ARMSTRONG |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 05/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|